Statistical Programmer III

Responsibilities

Coordinate programming activities across several trials with a given compound including publication and regulatory submission activities.

Develop programming specifications for analysis datasets, pooled datasets and deliverables in consultation with the statistician.

Review and provide feedback on statistical analysis plan, output shells, CRF, edit checks and other relevant trial documents.

Develop and comply with project/study programming standards and specifications following internal guidelines

Program according to specifications, analysis datasets, pooled datasets, listings, and figures for clinical trials and submission activities

Support quality control and quality audit of deliverables

Provide input as required at all meetings, discussions and activities covering aspects of Statistical Reporting on trial level activities

Track clinical trial milestones for statistical reporting deliverables.

Maintain records for all assigned projects and archiving of trial/project analysis and associated documentation.

Maintain efficient interfaces with internal and external customers and communicate effectively across line functions.

Skills:

At least 8 years work experience in a Statistical (SAS) programming role preferably supporting clinical trials or in the pharmaceutical industry (5 years for Masters in Mathematics, Statistics/Computer Science or health science graduates).

Advanced knowledge of / experience with SAS and other relevant programming software.

Proven experience in development of advanced MACROs with high programming efficiency; strong programming and problem-solving skills.

Proven experience in leading programmer support for multiple clinical trials and submission activities (or equivalent).

Expertise in programming according to specifications of analysis datasets, pooled datasets, listings, tables and figures for clinical trials and submission activities.

Working knowledge of database design/structures and basic statistics. Working experience in pooling analysis datasets across multiple clinical studies (or equivalent).

Good understanding of global clinical trial/project practices, procedures, methodologies.

Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).

Oncology experience preferred

Strong expertise in CDISC on the submission bucket including CRT programming will be a definite plus.

Intermediate knowledge of office tools

Fluent English (oral and written)

Excellent in people interaction and be a collaborative team player.

MUST HAVE Bachelor or Master's degree in life science, computer science, statistics or equivalent relevant degree.

Regards,

Akriti Gupta

Associate Recruiter(Scientific & Clinical Division)

Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960

Office: 973.967.3409 | Fax: 973.998.2599

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